FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2819205
·
Received November 5, 2012
Report
- Report Number
- 3004209178-2012-09923
- Event Type
- Injury
- Date Received
- November 5, 2012
- Report Date
- October 8, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID, 3093-28 LOT# V053146, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT NEVER RECEIVED THERAPEUTIC EFFECT. THE PATIENT'S DEVICE WAS EXPLANTED SO SHE COULD HAVE AN MRI OF HER SHOULDER. IT WAS ALSO REPORTED, THE PATIENT HAD BEEN USING A CATHETER SINCE 2010. IT WAS NOTED, THE CATHETER WAS PHYSICIAN PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |